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    PRESENTER:

    MARINA YUSOFF 2010672752

    NUR SYAFIQAH KAMARUDIN 2010847576

    CAROLINE APAU 2010488388

    AZWADI ALI 2009424756

    NURUL AFIQAH MOHD ZAKI 2010802956

    PRODUCTION OF

    1 KG PER YEAR

    INSULIN

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    PROCESS BACKGROUND/SELECTION

    CHAPTER 1

    http://c/Users/User/Desktop/presentation-dp/Prezi.exehttp://c/Users/User/Desktop/presentation-dp/Prezi.exe
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    INTRODUCTION

    Diabetes is one of the chronic diseases

    occurs when the glucose level in blood is

    increases due to breakdown ofcarbohydrates

    Insulin can help to convert excessive

    glucose into glycogen to be stored in liver

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    Human insulin can be produced by

    four different methods

    Extraction from human pancreas

    Chemical synthesis via individual amino

    acids. Conversion of pork insulin of

    semisynthesis.

    Fermentation of genetically engineeredmicroorganisms.

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    fermentation of genetically engineered

    microorganisms or can be simply called as

    recombinant DNA technology is chosen inthis project

    This is because this technique is safe,

    high recovery, high purity and almostsame with human insulin

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    Genetic Modification Organism

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    GENERAL PROCESS

    Consists of fourth teen important steps

    35 equipments and reactors involve in this

    batch process Duration for each batch is 6 days

    Production for each batch is 1.81 kg

    Production per year is 100 kg

    Downstream process to improve the

    quality of desired product

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    Fermentation process

    Cellisolation

    CellDisruptio

    n

    Centrifugation

    SolubilizeInclusionBodies

    (IB)

    CNBr-Cleavage

    SulfitolysisRefolding

    HICcolumn

    Enzymatic

    Conversion

    ReversePhase

    Chromatography

    Secondstage

    purification

    PolishingFreeze

    Dry

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    MARKET ANALYSISN

    CHAPTER 2

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    Insulin Worldwide Market

    Top 10 Coun tr ies Number of People with Diabetes

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    Insulin Worldwide Market

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    Trends in the Current DepressedMarket

    The Price of Insul in

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    Profit Margin

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    Break Even Analysis

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    Break Even Calculation

    Variab le Cos t

    Cost Item

    Formula value

    Raw Material RM 286 millions

    Waste Treatment RM 27 thousands

    Utilities RM 382 thousands

    Operating Labour RM 993 thousands

    Maintenance and repairs

    0.06FCI

    RM 13 millions

    Operating Supplies 0.009FCI RM 1.94 millions

    Total

    RM 302 millions

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    Break Even Calculation

    Fixed Cos t

    Cost Item Formula Value

    Fixed capital investment FCI RM 215 millions

    Local taxes and insurance 0.032FCI RM 6.88 millions

    Plant overhead costs 0.708 + 0.036FCI RM 8.45 millions

    Total

    RM 230 millions

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    Break Even CalculationTotal Revenue

    Total Revenue = Production of insulin x Price of

    insulin

    Production of insulin = 99.55 kg/year

    Price of insulin = RM 11.4 millions

    /year

    =

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    Break Even CalculationBreak Even Po int (BEP)

    BEP = (Fixed cost/ Contribution margin) x Production

    Contribution Margin = Revenues Variable Cost

    Contribution Margin = RM 834 millions

    Fixed Cost = RM 230 millions

    Production = 99.55 kg/year

    BEP = 27.50 kg/year need to be

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    Cumulative Cash FlowOperat ing Cost for the First Year

    Total Cost = Variable Cost + Fixed Cost

    Variable Cost = RM 302 millions

    Fixed Cost = RM 230 millions

    Total Cost = RM 532 millions

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    Cumulative Cash FlowCumulative Cash Flow Analysis

    Year

    Total cost

    Cumulative cash flow

    1 - 532,678,960 - 532,678,960

    2 - 372,514,550 - 905,193,510

    3

    1,136,861,000

    231,667,490

    4 1,136,861,000 1,368,528,490

    5 1,136,861,000 2,505,389,940

    6 1,136,861,000 3,642,250,490

    7 1,136,861,000 4,779,111,490

    8 1,136,861,000 5,915,972,490

    9 1,136,861,000 7,052,833,490

    10

    1,136,861,000

    8,189,694,490

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    Cumulative Cash FlowCumulat ive Cash Flow Diagram

    -0.2

    0

    0.2

    0.4

    0.6

    0.8

    1

    0 2 4 6 8 10 12CumulativeCashFlow

    (1010)(RM)

    Year

    Payback Period

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    ConclusionMarket Analysis o n Insul in Produc t ion

    Fixed Capital Investment is RM 215 millions and this cost isindependent of production rate.

    The Total Production Cost is RM 532 millions. It is summation

    of Variable Cost and Fixed Cost.

    The total insulin sale per year is RM 11.4 millions.

    Total Revenue = RM 1.14 billions.

    Net annual Profit = RM 700 millions

    Total Production = 99.55 kg/year

    BEP = 27.50 kg/year Productions

    Up the BEP, it has been estimated that the plant would gainsome profit and therefore this project can be considered as

    profitable as the production rate also is in conjunction with the

    supply and demand in Malaysia.

    The payback period is estimated about 3 years

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    SITE SELECTION

    CHAPTER 3

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    Chapter 3 : Site Selection

    Comparison between Senai, Pulau Indah and Gebeng between several

    criteria

    A rating evaluation has been made

    After all comparison, we decide to choose Gebeng Industrial Estate Phase

    3

    Gebeng Pulau Indah Senai

    Total Rating 38 37 35

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    Location Description

    a small town and main industrial area in Pahang state in Malaysia

    near Kuantan Port

    Kuantan is being identified as a Special Economic Zone (SEZ)

    located inside East Coast Economic Region (ECER)

    located only 5 kilometers from the Kuantan Port in Kuantan City

    25km away from the Kuantan town and 250km from the Kuala

    Lumpur

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    Land availability and prices

    selling prices RM 15 per sq

    can be bought with minimum 3 acres (130680 ft2) up to

    maximum 250 acres (10890000 ft2)

    So minimum price is RM 1,960,200 for 3 acres

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    Raw Material Availability

    Supply within the Malaysia and imported from the

    oversea

    Company that responsible for been supplier within

    Malaysia is Merck Sdn Bhd, Sigma-Aldrich (M) Sdn.Bhd, and Fisher CW Medical (M)

    Raw materials will be transported from these company

    via road

    The other raw material imported from oversea istransported to nearest airport and port.

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    Transportation Network

    Gebeng by-pass between Gebeng Industrial Estate andKuantan Port

    The by-pass will directly link with the East CoastExpressway to connect Kuala Lumpur with Kuantan

    Kuantan Port is located only 5 kilometers from theGebeng Industrial Estate

    Sultan Ahmad Shah Airport, Kuantan is approximately35km from Gebeng Industrial Estate and connected via

    Jalan Pintasan Kuantan Not compacted with other activities, so smooth trafficking

    of the import and exporting process

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    Availability of Utilities

    main electricity supplier in Gebeng Industrial Estate is

    Tenaga Nasional Berhad (TNB)

    Phase I and II is supported by its 132/11kV main intake,

    for Phase III, two sources of electricity supply areavailable which are and 12/275kV main intake

    water supply is Semambu Water Treatment Plant

    capacity 2MG/D

    main telecommunication supplier is Telekom Malaysiafor instance Integrated Systems Digital Network (ISDN),

    digital line, MAYPAC, Internet and video conferencing

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    Availability of Labour

    main labourssources is Kuantan population is

    approximately 607,778 persons.

    Also involves Kemaman area

    Pahang provides access to skilled manpower as whichcan be acquired numerous institutions of further studies

    Universities Others Facilities

    University Teknology MARA

    University Malaysia Pahang

    International IslamicUniversity Malaysia

    Kolej Islam Pahang,

    Politeknik Sultan Haji Ahmad

    ShahKolej Komuniti Kuantan Kolej

    ShahPutra Kuantan

    Kolej Poly-Tech MARA

    Institut Kemajuan Ikhtisas

    Pahang (IKIP) College

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    Government Incentives

    Development of Gebeng Phase III which will beattraction for the investor to Pahang

    The Eastern Industrial Corridor, which is the governmentbacked economic region developed into an ultra-modernindustrial region

    Accelerated capital allowance provides a specialallowance, where the capital expenditure is written offwithin 3 years

    water supply to 64 MG/D Building of new pipes and water tanks in Gebeng

    Industrial Estate

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    MATERIAL BALANCE

    CHAPTER 4

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    General Mass alance

    Equation

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    1 batch approximately 6 days

    100 kg/ yr X 1 yr/ 330 days X 6days/batch

    = 1.818 kg/batch 330 days/ 1 yr X 6 days/ batch = 55

    batches per year

    Production rate = 100 kg/year

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    The calculation is based on the production rate of 100 kg/year of

    insulin.

    The target production rate per batch is 1.818 kg/batch.

    Operating days for the plant is 330 days per year, 24 hours daily.

    The system is a steady-state operation.

    The system behaves as an ideal condition.

    No leakage in the pipes or vessels inside the plant.

    All the catalysts used during the process do not contribute to the

    mass inside the system. The total input of substances to compressor, pump, valve, mixer or

    heat exchanger is equal to the total output.

    All calculations are done in kg/batch

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    TSB + O2+ N2+ NH3+ H2O + kanamycinbiomass

    (E.coli)+ O2+ N2+ NH3+ H2O+CO2+ kanamycin + ATPs

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    Overall mass balance: total in = total output

    The percentage of air consists of 21% of oxygen, 79% of

    nitrogen

    870 kg/batch of Ammonium gas is purge into this system Basis of 43 504 kg/batch air is purge into the fermenter

    system

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    1.4% of oxygen from respiration of bacteria cell is

    release as carbon dioxide

    Conversion process for TSB is 95%

    0.5 kg biomass can be generate for every 1 kg of TSBconsumed

    kanamycin does not take part in the reaction so that total

    input = total output

    74 % of water will be increase after undergofermentation process due to biological process that

    occurred.

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    Percentage error of calculation:

    Manual calculation = 1.800kg/batch

    Simulation = 1.810 kg/batch Target production = 1.814kg/batch

    (1.810-1.800) /1.810 X 100% = 0.55 %

    (1.814-1.800)/1.814X 100% = 0.77 %

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    ENERGY BALANCE

    CHAPTER 5

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    Important in worldwide manufacturing plant to reduce the

    cost and energy consumption.

    To analyze and optimize the uses of energy in designinga plant.

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    The system is assume as an open system

    Q-Ws= H+Ek+Ep

    The equation reduced to

    = =

    =Hf+

    = Hf+ [ ]

    Ws, Ek and Ep =0

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    1. Assumptions:

    Open system (Q=H) and steady state process

    - No moving parts considered in the system

    - All equipments are static

    Heat from pressure change is neglected

    All streams and reactions occur in liquid phase- Occurs in homogeneous mixture. Thus, solid and gas is not taken into

    account.

    Heat of mixing, Hm is neglected

    2. Basis:

    Tref = 25C = 298.15K Pref= 1atm Mass flowrate is in kg/hour

    Heat capacity,Cp get from SUPERPRO library

    Using heat of formation method due to the facts that heat of reaction method for certain standard conditions is

    unknown.

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    ENVIRONMENTAL AND SAFETY CONSIDERATION

    CHAPTER 6

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    Role of chemical engineer

    Lack of consideration

    Negative impact

    -Human

    -Animal

    -Aquatic life

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    Follow the Malaysia Act & Regulation

    -OSHA

    -Environment Quality Act

    (Air pollution, Scheduled Waste)

    -Biosafety Act

    Hazard

    HIRARC

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    HAZARDOUS WASTE

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    Classification

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    Treatment

    Biological Treatment

    1.Inject with Chlorine

    2.Sterilize the waste3.Send to the Jabatan Alam Sekitar

    Chemical Treatment

    Recycle

    Send to the Jabatan Alam Sekitar

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    Management

    Recycle

    Waste area

    Labeling the waste

    Put the sign of hazardous area

    Disposal to the sanitary landfill